PV Auditing & QMS Lead

PERSOL; Chandigarh; Hybrid; INR 2,800,000 - 4,000,000; Full time

Job summary

Persol is seeking a Pharmacovigilance (PV)/GCP QA Lead in India to independently perform QA activities and liaise with the Quality Head. The role requires handling client audits, regulatory inspections, and the management of deviations and CAPAs, along with RCAs and CAPA development guidance.

Candidate should have around 10 years of PV/GCP QA experience, strong English proficiency, and an auditing certification. Travel may be required as part of audits and inspections.

Qualifications

• Degree in Life Sciences (Pharmacy, Microbiology, Biochemistry or Biotechnology).
• About 10 years of PV/GCP QA experience.
• Auditing certification (ISO lead auditor/assessor).
• Excellent written and spoken English.

Responsibilities

• Lead/perform QA activities related to PV and GCP independently or with QA head.
• Manage client audits and regulatory inspections.
• Handle quality issues and CAPAs; perform RCAs.
• Develop CAPA plans and guidance for staff.
• Plan internal and vendor audits using risk-based methods.
• Prepare audit schedules and perform internal/vendor audits.
• Maintain controlled documents (SOPs, templates).
• Review project quality data and perform trend analyses.
• Ensure adherence to GVP and GCP requirements.

Skills

English proficiency

Attention to detail

Education

Life Sciences degree (Pharmacy, Microbiology, Biochemistry or Biotechnology)

Tools

MS Office

Job description

Pharmacovigilance (PV)/GCP QA Lead

Performing QA activities (listed below) independently and/or in liaison with the Quality Head:

• Handling client audits and regulatory inspections
• Management of quality issues/events/deviations and CAPAs
• Performing RCAs and/or providing guidance to the staff in performing RCAs
• Developing CAPA plans and/or providing guidance to the staff in developing and

implementing CAPAs

• Planning internal and vendor audits using a risk-based assessment and maintaining

the audit planner in accordance with applicable GVP and GCP requirements

• Preparing audit schedules and performing internal audits and audits of vendors
• Maintaining/managing controlled documents such as SOPs, templates etc.
• Liaising with Project Leads/Functional Heads for ensuring implementation of

applicable KPIs/metrics

• Reviewing the quality and compliance data of various projects; performing trend

analyses and interpretation of analyses

• Computer system validation activities

Qualifications and skills:

• Degree in any of the Life Sciences disciplines (Pharmacy, Microbiology, Biochemistry,

Biotechnology etc.)

• Experience of ~10 years in PV and/or GCP and Quality Assurance
• High level of proficiency in English, particularly written English
• Auditing certification (e.g. ISO lead auditor/assessor certification)

Job Description

• Auditing experience, specially planning for internal and vendor audits using risk-based approach
• Experience in handling client/partner audits, and regulatory inspections
• Experience in performing RCAs and development of CAPAs
• Working knowledge of drug safety/GCP/regulatory requirements
• Strong written and verbal communication skills
• Detail oriented
• Passion for delivering high quality work
• Ability to manage multiple and varied tasks effectively
• High level of flexibility and ability to prioritize work
• Ability to perform under stringent timelines
• Ability to work independently or as a team member
• Excellent problem-solving skills and decision-making skills
• Ability to understand, interpret, analyse and present data
• Computer proficiency: proficiency in the use of MS Office suite (Word/Excel/ Power

Point)

• Ability and willingness to travel, as needed